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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Patient were recruited between September 2006 and May 2008.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Patients who were naïve to lipid-lowering agent or patients who were treated with lipid-lowering agent and had 4 week' wash-out period were enrolled in the study. The eligible patients will be allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio.

Reporting Groups

Description

Vytorin

Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.

Atorvastatin

Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.

Participant Flow for 2 periods

Period 1: Base Study (12 Week Follow-up)

Vytorin

Atorvastatin

STARTED

118

111

COMPLETED

101

99

NOT COMPLETED

17

12

Adverse Event

1

0

Death

0

1

Protocol Violation

7

3

Withdrawal by Subject

9

8

Period 2: 24 Weeks Follow-up (3 Centers)

Vytorin

Atorvastatin

STARTED

35 [1]

34 [2]

COMPLETED

29

28

NOT COMPLETED

6

6

Adverse Event

1

0

Lost to Follow-up

2

2

Protocol Violation

2

1

Withdrawal by Subject

1

3

[1]

66 Patients did not continue in the additional 12 week extension, for the 24 weeks follow-up period.

[2]

65 Patients did not continue in the additional 12 week extension, for the 24 weeks follow-up period.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Vytorin

Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.

Atorvastatin

Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.